The Senior Director, Late-Stage Readiness Lead will prepare the company's Development functions for Phase 3 clinical studies and Biologics License Applications, coordinating with various teams to ensure readiness, resource planning, and strategic alignment. This role involves gap analysis, risk management, and optimizing processes for successful outcomes in clinical trials and submissions.

The Associate Director of Statistical Programming at Apogee Therapeutics will lead statistical programming for clinical trials, manage programming teams and CROs, ensure data quality, and collaborate with cross-functional teams. This role involves developing programming processes, mentoring staff, and providing statistical oversight to support clinical goals.

The Director of Biostatistics will lead statistical design and analysis for clinical studies, providing expert input on regulatory communications and methodologies, and overseeing CRO partnerships. Responsibilities include reviewing protocols, conducting statistical analyses, and ensuring statistical integrity in compliance with regulatory standards.

The Director of Quality Control will oversee QC technical infrastructure and operations, manage partnerships with external labs, establish testing strategies for biologics, and ensure compliance with GMP testing requirements.

The Associate Director of GxP R&D Systems will lead the integration and administration of GxP systems, ensuring compliance and data integrity while collaborating with cross-functional teams. Responsibilities include designing solutions for quality and regulatory processes, leading system integration, ensuring compliance with GxP requirements, and fostering team collaboration.

The Associate Director, Biomarker Discovery and Development will lead biomarker strategy and analysis for clinical studies, manage the biomarker assay group, and collaborate with cross-functional teams to support biomarker discovery and validation efforts.